RecruitingInterventional

Could a dietetic led supported weight loss programme help people with cystic fibrosis who have excess weight?

This study investigates if a special weight loss program is helpful and safe for adults with cystic fibrosis (CF) who have excess weight. Many people with CF are now living longer thanks to new medicines, but some have gained more weight than is healthy, which could lead to other health problems like heart disease. Since there's no clear guidance on weight loss for people with CF, this research aims to see if such a program is practical and safe. Participants will receive one-to-one remote support from a dietitian over 24 weeks. Researchers will monitor their health and gather feedback to understand their experiences and whether the program fits into their lives. The goal is to develop better support for people with CF in the future.

At a glance

Status

Recruiting

Sponsor

University of Oxford

Enrolment target

Start

26 Jan 2026

Estimated completion

31 Dec 2026

Obesity and other hyperalimentation, Metabolic disorders

What is this study about?

Cystic fibrosis (CF) is a condition that affects many parts of the body, especially the lungs and digestive system. In the past, people with CF were often encouraged to gain as much weight as possible, as being underweight was a big problem. However, with amazing new medicines, people with CF are living much longer and healthier lives. This has led to a new challenge: some people with CF now find they have gained too much weight.

Having too much weight can bring other health risks, such as heart problems and certain cancers, which people with CF are already more prone to. Because this is a new situation, doctors and dietitians aren't sure yet how best to help people with CF manage their weight safely. There are questions about whether losing weight is safe, if it fits with the many treatments people with CF already have, and how it works with past advice to eat lots of calories.

This study, called EASE-CF, wants to find out if a guided weight loss program is practical and safe for adults with CF who have excess weight. It's a first step to see if a bigger study should be done. The results will help create better advice and support for people with CF in the future, making sure they can stay as healthy as possible as they get older.

Key takeaways

This study aims to find a practical and safe way for adults with CF to manage excess weight.
New CF medicines have led to some people gaining more weight than is healthy, creating a new health challenge.
Participants will receive remote, one-on-one dietitian support for 24 weeks if in the weight loss group.
Your health will be closely monitored throughout the study to ensure safety.
Your feedback is vital to help design better weight management programs for people with CF in the future.
The study was designed with input from CF patients to make it as helpful as possible.

Who may be eligible?

This study is looking for adults aged 18 or over who have been diagnosed with cystic fibrosis and are carrying extra weight. Even if you've had a lung or liver transplant, you might still be able to join. You'll need to be able to talk in English, or have someone who can help you understand and participate.

However, some things might mean you can't take part. For example, if you are pregnant, breastfeeding, or planning to get pregnant during the study. You also can't join if you've recently lost a lot of weight on your own (10% or more in the last 6 months), or if you have serious kidney or liver problems. If you are currently using feeding tubes or are already involved in another clinical trial where you're receiving a specific treatment, you also won't be able to join this study.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Do you have a diagnosis of cystic fibrosis?
Do you have excess weight (a BMI of 27 or higher, or 25 or higher if you are of Black, Asian, or minority ethnic origin)?
Are you able to speak English or have someone who can translate for you?
Are you not currently pregnant, breastfeeding, or planning a pregnancy during the study?
Have you not lost a lot of weight (10% or more) in the last 6 months?

Answer every question to see your result.

What does participation involve?

If you join this study, you'll be randomly placed into one of two groups. One group will follow a weight loss program, and the other will receive standard care from their dietitian. If you're in the weight loss program group, you'll get one-to-one support from a specialist dietitian over the phone or online. This support will help you learn how to eat fewer calories to lose weight over 12 weeks, and then help you keep that weight off for another 12 weeks. So, the direct program support lasts for about 6 months (24 weeks).

Throughout the study, the research team will regularly check in on your lung health and overall well-being to make sure you're safe. They'll also ask about your experiences and thoughts on the program. Your feedback is really important as it will help them make the program better for others in the future. At the end of the study, if you were in the standard care group and still want help with weight loss, you'll be offered a special one-off consultation with a CF dietitian to create a plan.

Potential risks and benefits

By taking part in this study, you'll be helping researchers understand how to best support people with cystic fibrosis in the future, which is a major benefit for the whole CF community. If you are in the weight loss program, you might achieve weight loss, which could improve your health and lower your risk of other conditions. The study team will closely monitor your health to ensure your safety, and they don't expect any serious side effects from the dietary changes. You are free to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (4)

John Radcliffe Hospital
Approximate
Oxford, England
Southampton General Hospital
Approximate
Southampton, England
King's College Hospital NHS Foundation Trust
City only
London, England
University Hospitals of North Midlands NHS Trust
City only
Stoke-on-trent, England

Common questions

What is cystic fibrosis?

Cystic fibrosis (CF) is a genetic condition that mainly affects the lungs and digestive system, making it hard to breathe and digest food properly.

Why is weight loss being studied now for CF patients?

New medicines mean people with CF are living longer, and some have gained too much weight. This study explores safe ways to manage weight, as there's no clear guidance for CF patients yet.

Will I have to pay to participate?

No, there are no costs for taking part in this study. The support, check-ups, and dietitian consultations are all covered by the research.

How often will I need to see the dietitian?

The support from the dietitian will be remote (by phone or online) and will be tailored to your needs within the 24-week program. The study will monitor your health regularly.

What happens if I'm in the standard care group?

If you're in the standard care group, you'll continue with your usual dietitian visits. At the end of the study, you'll be offered an extra consultation with a CF dietitian to discuss weight loss if you wish.

How to find out more

Joanna Snowball

joanna.snowball@phc.ox.ac.uk +44 01865 661767 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.